At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A 24-week, Multicentre, Randomised, Double-blind,Age-stratified, Placebo Controlled Phase III Study With an 80-week Extension Period to Evaluate the Efficacy and Safety of Dapagliflozin 10 mg Once Daily in Patients With T2DM and Cardiovascular Disease, Who Exhibit Inadequate Glycaemic Control on Usual Care
In Brief
A Phase 3 clinical trial evaluating Dapagliflozin and Placebo for Type 2 Diabetes Mellitus and 2 related conditions. Completed, enrolled 964 participants across 135 sites in 10 countries.
Detailed Summary
This study is carried out to assess whether dapagliflozin improves glycemic control, decreases fasting plasma glucose levels, body weight and blood pressure when added to patient's existing medications and how it compares with their usual treatment without added dapagliflozin. Safety data will be collected and analysed to confirm that treatment with dapagliflozin is safe and well tolerated in patients who have diabetes and cardiovascular disease
Study Details
Timeline
Interventions
10 mg tablet, oral, once daily, 24- week treatment and 80-week extension period
matching placebo tablet, oral, once daily, 24- week treatment and 80-week extension period